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Central Services Associate I
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Central Services Associate I : MedImmune, LLC.
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| Job Number |
02113 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Gaithersburg
Maryland
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| Salary (year) |
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| Start Date |
2/9/2010 |
| Industry |
Biotech |
| Job Type |
Clinical-Operations |
| Relocation |
Not Required |
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| Description |
Description
Title: Clinical Services Associate I
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02113
Position Summary:
The Central Services Associate I supports the Clinical Study Teams with a special emphasis on study start up activities and CTMS support.
Major Duties and Responsibilities:
• Contributes to the clinical study team through all study phases from study start-up, maintenance through study closure.
• Set up , populate and accurately maintain key study information in the appropriate system (e.g. CTMS) Major tasks include:
? Input trial descriptive information (indication, phase, design, etc)
? Setup trial configuration for enrollment tracking and monitoring (setup countries and sites, study visit design, monitoring setup, documents template setup, checklist setup, etc)
? Maintain trial team list, site contact and investigator information
? Track regulatory documents and study documents
• Coordinate with the Resource Performance Management group, request, distribute and track confidentiality agreements for sites
• Distribute, retrieve and track feasibility and capability questionnaires to sites as directed by study teams
• Distribute, retrieve and track site regulatory documents as requested by study teams
• Partner with clinical study sites to track scientific review committee meetings, IRB meetings, Ethic Review committees to drive timely procurement of study start up documents.
• Complete QC on regulatory documents
• Prepare completed regulatory packages for CPM or designee approval
• Process completed signed regulatory packets to regulatory for final approval
• Transmit appropriate documents to the Trial Master File (TMF)
• Work with Clinical Research Associates (CRAs) or site monitors to ensure collection of outstanding documents during site visits.
• Assist with preparation for internal or external meetings , including Investigator Meetings, training meetings and or Vendor Meetings
• Perform data entry and check quality , consistency and integration of clinical sites data in the applicable systems
As directed by the CPM or Lead CRA
• Initiate and track drug shipment requests
• Assist in the preparation and assembly of Study Specific Investigator site binders
About the Organization
My company shares my
passion for helping to improve human health around the world."
"This is My MedImmune."
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.
Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
Company Information
MedImmune, LLC. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
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| Requirements |
Position Requirements
Special Skills/Abilities:
• Develops working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH Good Clinical Practice (GCP) guidelines
• Successful completion and thorough comprehension of assigned training curriculum
• Demonstrates computer proficiency and the ability to develop advanced computer skills to increase efficiency in day-to-day tasks
• Develops basic knowledge of therapy area through experience and review of scientific literature
• Demonstrates analytical thinking, concern for standards, concern for impact, good team skills including cooperation, willingness to learn from others, sharing relevant information, adaptability, self-control, tenacity, and conflict resolution skills
• Demonstrates organization and time management skills, detail-orientation, and ability to multi-task
• Develops ability to prepare presentation materials
• Demonstrates professionalism and mutual respect
• Demonstrates ability to follow tasks through to completion
• Demonstrates excellent administrative, interpersonal, organizational, time management skills
• Demonstrates computer proficiency and has the ability to develop advanced computer skills to increase efficiency in day to day tasks
• Develops a working knowledge of aspects of clinical data flow and the processes and systems that facilitate receipt and validation of clinical data for analysis and reporting.
Job Complexity:
• Develops solutions to routine problems of limited scope
• The ability to multi-task and be able to prioritize work load based on business demands
• Contributes to the completion of organizational projects and goals
• Failure to achieve results can normally be overcome without serious effect on schedules and programs
Supervision:
• Work is closely supervised and regularly reviewed
• Follows established procedures
• Follows specific, detailed instructions
Educational Requirements
Requirements/Qualifications:
Education:
• University degree or comparable experience equal to the requirements of the position.
Requirements/Qualifications:
Other:
• Good knowledge of spoken and written English
• Excellent written and verbal communication skills
• Good Organizational and analytical skills
• Detail-oriented
• Ability to work independently, as well as in a team environment
• Ability to prioritize and manage multiple tasks
• Computer proficiency
Experience:
• Can verbalize a good understanding of the clinical study process and familiarity with medical terminology
• One year of previous administrative training/experience or clinical research site coordination
• Ability to utilize all relevant portions of clinical trial management system
• Sustains a working knowledge of ICH GCP and relevant regulatory requirements
MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune’s approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune’s approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.
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